FDA Adverse Event
Other
Summary report: N
ENT PLASMA WAND
MDR report key: 2093601
·
Received April 15, 2011
Report
- Report Number
- 2951580-2011-00062
- Event Type
- Other
- Date Received
- April 15, 2011
- Date of Event
- January 1, 2006
- Report Date
- April 15, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K070374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT IS UNK. PER JOURNAL ARTICLE, THE PROCEDURE WAS PERFORMED BETWEEN (B)(6) 2006 AND (B)(6) 2007. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED.
Description of Event or Problem · 1
PER JOURNAL ARTICLE, IT WAS REPORTED A PT HAD COMPLICATIONS FOLLOWING A TONSILLECTOMY PROCEDURE INVOLVING POSTOPERATIVE BLEEDING ON DAY 2 AND WAS HOSPITALIZED AND TREATED WITH A BLOOD TRANSFUSION (2 UNITS) AND KETOBEMIDONE HYDROCHLORIDE. AFTER 5 DAYS, THE PT WAS DISCHARGED IN GOOD CONDITION. THE PROCEDURE WAS PERFORMED BETWEEN (B)(6) 2006 AND (B)(6) 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENT PLASMA WAND | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |